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| ID | Type | Description | Link |
|---|---|---|---|
| rhuFAB v2 | Other Grant/Funding Number | Genentec |
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
| Novartis Pharmaceuticals | INDUSTRY |
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Does a new add on (or adjunctive) therapy used in glaucoma surgery improve the success of trabeculectomy? Ranibizumab may offer benefit similar to mitomycin C in preventing epi-scleral fibrosis while avoiding the well known complications of mytomycin C which include late bleb leaks, hypotony and infection.
This is an open-label, single center trial with two arms for patients who underwent guarded filtration surgery to control glaucoma. The control will consist of patients randomly assigned to receive inter-operative mitomycin C 0.4 mg/ml which is applied in a standard fashion with a soaked pledget inserted in the sub-tenon's space during surgery. The study arm will consist of patients randomly assigned to receive a sub-tenon injection of Ranibizumab 0.5 mg/0.05mL with a 30 gauge needle on a tuberculin syringe at the termination of the surgery. No mitomycin C will be applied.
Post operative follow-up will consist of a minimum of 6 visits during a one year period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Ranibizumab 0.5mg (0.05mL) injection | Experimental | Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery. This intra-operative adjunct therapy was administered sub-conjunctivally 8-10mm posteriorly to the limbus as an antifibrotic agent. |
|
| B: Mitomycin C 0.4 mg/ml sponge | Active Comparator | Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabeculectomy surgery. This is the typical method used as an antifibrotic agent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Percentage of participants with ocular adverse events and other adverse events as identified by eye examination, physical examination, subject reporting and changes in vital signs one year post-operatively. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Post-Operative Requirement for Glaucoma Medication | Mean number of glaucoma medications used by each participant over the course of one year post-operatively. | 1 day, 2 wks, 1, 3, 6 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Pro, MD | Wills Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wills Eye Hospital, Glaucoma Service | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25019269 | Result | Pro MJ, Freidl KB, Neylan CJ, Sawchyn AK, Wizov SS, Moster MR. Ranibizumab versus mitomycin C in primary trabeculectomy--a pilot study. Curr Eye Res. 2015 May;40(5):510-5. doi: 10.3109/02713683.2014.935441. Epub 2014 Jul 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment 1 (Ranibizumab 0.5mg) | Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery. Ranibizumab: Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery |
| FG001 | Treatment 2 (Mitomycin C 0.4 mg/ml) | Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabeculectomy surgery. Mytomycin C 0.4 mg/ml: Mitomycin C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment 1 (Ranibizumab 0.5mg) | Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery. Ranibizumab: Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery |
| BG001 | Treatment 2 (Mitomycin C 0.4 mg/ml) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adverse Events | Percentage of participants with ocular adverse events and other adverse events as identified by eye examination, physical examination, subject reporting and changes in vital signs one year post-operatively. | Posted | Number | percentage of participants | 12 months |
|
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At each of the six post-operative follow-up visits, patients were assessed for visual acuity, intraocular pressure, anterior chamber depth, optic disc swelling, choroidal detachment, choroidal folds, macular/retinal folds, and needing of the bleb.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment 1 (Ranibizumab 0.5mg) | Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery. Ranibizumab: Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| optic nerve swelling | Eye disorders | Systematic Assessment |
Small sample size. Different surgical techniques among multiple surgeons.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prinicipal Investigator | Wills Eye Hospital | 484-434-2700 | mpro2020@yahoo.com |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| D016685 | Mitomycin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Patients requiring trabeculectomy were randomly assigned to either MMC or Ranibizumab during surgery.
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| Mitomycin (MMC) | Drug | Mitomycin (MMC) C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery. |
|
|
Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabeculectomy surgery. Mytomycin C 0.4 mg/ml: Mitomycin C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Post-Operative Requirement for Glaucoma Medication | Mean number of glaucoma medications used by each participant over the course of one year post-operatively. | Posted | Mean | 95% Confidence Interval | number of glaucoma medications used | 1 day, 2 wks, 1, 3, 6 and 12 months |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 12 |
| 12 |
| EG001 | Treatment 2 (Mitomycin C 0.4 mg/ml) | Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabeculectomy surgery. Mytomycin C 0.4 mg/ml: Mitomycin C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery. | 0 | 12 | 0 | 12 | 2 | 12 |
| choroidal detachment | Eye disorders | Systematic Assessment |
|
| choroidal folds | Eye disorders | Systematic Assessment |
|
| macular/retinal folds | Eye disorders | Systematic Assessment |
|
| needling of the bleb | Eye disorders | Systematic Assessment |
|
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| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D008937 | Mitomycins |
| D045563 | Indolequinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
| D001389 | Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| 1 month |
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| 3 months |
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| 6 months |
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| 12 months |
|